Turkey adopts regulation on ‘emergency use authorization’ for COVID-19 vaccine

With a new regulation published in the Official Gazette, the Pharmaceuticals and Medical Devices Agency of Turkey can now give emergency use authorization for vaccines until comprehensive data can be obtained as to their efficacy, safety and quality.

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Turkey adopts regulation on ‘emergency use authorization’ for COVID-19 vaccine

* Photo: Anadolu Agency (AA)

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"The Regulation Foreseeing Amendments to the Regulation on Human Medicinal Products Licensing" of the Pharmaceuticals and Medical Devices Agency of Turkey has entered into force after it was published in the Official Gazette today (December 18).

As part of this amendment, a clause has been added at the end of the Article 10 of the Regulation titled "Licensing in Special Cases."

According to this new amendment, in the event of "exceptional cases posing a serious threat to public health and considered to be an epidemic disease by the World Health Organization (WHO) or the Ministry" of Health, the Pharmaceuticals and Medical Devices Agency of Turkey can now give "Emergency Use Authorization (EUA) for the vaccines about which no comprehensive data can yet be obtained as to their efficacy, safety and quality until the related data can be obtained."

Turkey ordered COVID-19 vaccine from China

While Turkey is also conducting its own vaccine research, as announced by the Ministry of Health on previous occasions, the country has also made an agreement with China to import 50 million doses of CoronaVac, a vaccine developed by the Sinovac company and still in the 3rd trial phase.

However, this agreement has caused concerns among the public, especially about the efficacy and safety of the vaccine, as the results of the phase 3 clinical trials have not yet been shared with the public.

Health Minister Fahrettin Koca previously indicated that the vaccine would be tried in the relevant units in Turkey for two weeks after arriving in the country. However, Sinovac has not yet delivered the order. While the Minister said that the first vaccination would begin on December 11, so seven days ago, this date has now been postponed to the first week of 2021.

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(TP/SD)